Overview

The marketing authorisation for Lextemy has been withdrawn at the request of the marketing-authorisation holder.

Lextemy : EPAR - Medicine overview

Reference Number: EMA/133097/2021

English (EN) (737.8 KB - PDF)

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български (BG) (827.52 KB - PDF)

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español (ES) (736.34 KB - PDF)

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čeština (CS) (808.36 KB - PDF)

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dansk (DA) (733.39 KB - PDF)

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Deutsch (DE) (739.84 KB - PDF)

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eesti keel (ET) (722.36 KB - PDF)

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ελληνικά (EL) (831.27 KB - PDF)

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français (FR) (738.22 KB - PDF)

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hrvatski (HR) (759.51 KB - PDF)

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italiano (IT) (734.5 KB - PDF)

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latviešu valoda (LV) (1.42 MB - PDF)

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lietuvių kalba (LT) (762.7 KB - PDF)

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magyar (HU) (837.62 KB - PDF)

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Malti (MT) (812.65 KB - PDF)

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Nederlands (NL) (735.84 KB - PDF)

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polski (PL) (809.77 KB - PDF)

First published: 14/12/2021
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português (PT) (737.12 KB - PDF)

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română (RO) (762.04 KB - PDF)

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slovenčina (SK) (808.39 KB - PDF)

First published: 14/12/2021
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slovenščina (SL) (802.42 KB - PDF)

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Suomi (FI) (732.68 KB - PDF)

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svenska (SV) (734.03 KB - PDF)

First published: 14/12/2021
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Product information

Lextemy : EPAR - Product Information

English (EN) (1.69 MB - PDF)

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български (BG) (3.49 MB - PDF)

First published: 14/12/2021
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español (ES) (1.72 MB - PDF)

First published: 14/12/2021
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čeština (CS) (2.9 MB - PDF)

First published: 14/12/2021
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dansk (DA) (1.7 MB - PDF)

First published: 14/12/2021
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Deutsch (DE) (1.85 MB - PDF)

First published: 14/12/2021
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eesti keel (ET) (1.75 MB - PDF)

First published: 14/12/2021
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ελληνικά (EL) (3.64 MB - PDF)

First published: 14/12/2021
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français (FR) (1.83 MB - PDF)

First published: 14/12/2021
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hrvatski (HR) (1.76 MB - PDF)

First published: 14/12/2021
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íslenska (IS) (1.73 MB - PDF)

First published: 14/12/2021
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italiano (IT) (1.75 MB - PDF)

First published: 14/12/2021
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latviešu valoda (LV) (2.97 MB - PDF)

First published: 14/12/2021
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lietuvių kalba (LT) (1.81 MB - PDF)

First published: 14/12/2021
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magyar (HU) (2.96 MB - PDF)

First published: 14/12/2021
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Malti (MT) (3.03 MB - PDF)

First published: 14/12/2021
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Nederlands (NL) (1.72 MB - PDF)

First published: 14/12/2021
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norsk (NO) (1.67 MB - PDF)

First published: 14/12/2021
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polski (PL) (2.99 MB - PDF)

First published: 14/12/2021
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português (PT) (1.77 MB - PDF)

First published: 14/12/2021
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română (RO) (1.79 MB - PDF)

First published: 14/12/2021
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slovenčina (SK) (3.07 MB - PDF)

First published: 14/12/2021
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slovenščina (SL) (2.91 MB - PDF)

First published: 14/12/2021
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Suomi (FI) (695.48 KB - PDF)

First published: 14/12/2021
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svenska (SV) (675.93 KB - PDF)

First published: 14/12/2021
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Lextemy : EPAR - All authorised presentations

English (EN) (588.96 KB - PDF)

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български (BG) (652.99 KB - PDF)

First published: 14/12/2021
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español (ES) (588.36 KB - PDF)

First published: 14/12/2021
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čeština (CS) (642.07 KB - PDF)

First published: 14/12/2021
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dansk (DA) (591.92 KB - PDF)

First published: 14/12/2021
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Deutsch (DE) (589.09 KB - PDF)

First published: 14/12/2021
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eesti keel (ET) (587.73 KB - PDF)

First published: 14/12/2021
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ελληνικά (EL) (649.48 KB - PDF)

First published: 14/12/2021
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français (FR) (603.46 KB - PDF)

First published: 14/12/2021
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hrvatski (HR) (621.04 KB - PDF)

First published: 14/12/2021
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íslenska (IS) (589.72 KB - PDF)

First published: 14/12/2021
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italiano (IT) (591.56 KB - PDF)

First published: 14/12/2021
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latviešu valoda (LV) (640.4 KB - PDF)

First published: 14/12/2021
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lietuvių kalba (LT) (624.27 KB - PDF)

First published: 14/12/2021
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magyar (HU) (620.83 KB - PDF)

First published: 14/12/2021
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Malti (MT) (643.86 KB - PDF)

First published: 14/12/2021
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Nederlands (NL) (590.31 KB - PDF)

First published: 14/12/2021
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norsk (NO) (590.2 KB - PDF)

First published: 14/12/2021
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polski (PL) (643.12 KB - PDF)

First published: 14/12/2021
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português (PT) (591.84 KB - PDF)

First published: 14/12/2021
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română (RO) (623.67 KB - PDF)

First published: 14/12/2021
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slovenčina (SK) (643.6 KB - PDF)

First published: 14/12/2021
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slovenščina (SL) (619.65 KB - PDF)

First published: 14/12/2021
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Suomi (FI) (589.93 KB - PDF)

First published: 14/12/2021
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svenska (SV) (590.45 KB - PDF)

First published: 14/12/2021
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Product details

Name of medicine
Lextemy
Active substance
bevacizumab
International non-proprietary name (INN) or common name
bevacizumab
Therapeutic area (MeSH)
  • Colorectal Neoplasms
  • Breast Neoplasms
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Uterine Cervical Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XC07

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Authorisation details

EMA product number
EMEA/H/C/005611

Biosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Marketing authorisation holder
Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Opinion adopted
25/02/2021

Assessment history

CHMP summary of positive opinion for Lextemy

Reference Number: EMA/CHMP/87640/2021

English (EN) (684.97 KB - PDF)

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Lextemy : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/680012/2021

English (EN) (7.07 MB - PDF)

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More information on Lextemy

Public statement on Lextemy : Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/379539/2021

English (EN) (123.51 KB - PDF)

First published:
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